Country Approval Specialist - Client-dedicated
Country Approval Specialist - Client-dedicated
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of lifechanging therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.
Our global Clinical Operations colleagues within our PPD clinical research services provide endtoend support for clinical trials from study start up to monitoring through to study close out across commercial and government contracts. Together we help clients define and develop clinical programs minimize delays and execute highquality costefficient clinical studies.
Position Overview:
As a Country Approval Specialist you will participate in the management and preparation review and coordination of Country Submissions in line with global submission strategy in order to activate investigative sites. You have a strong attention to detail taking ownership of the accuracy of these documents while holding yourself and others accountable. You
Essential Functions:
- Prepares reviews and coordinates under guidance local regulatory submissions (MoH EC additional special national local applications if applicable e.g. gene therapy approvals viral safety dossiers import license) in alignment with global submission strategy.
- Provides under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
- Provides project specific local SIA services and coordination of these projects.
- May have contact with investigators for submission related activities.
- Keycontact at country level for either Ethical or Regulatory submissionrelated activities.
- Coordinates under guidance with internal functional departments to ensure various site startup activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
- Achieves PPDs target cycle times for site.
- May work with the startup CRA(s) to prepare the regulatory compliance review packages as applicable.
- May develop country specific Patient Information Sheet/Informed Consent form documents.
- May assist with grant budgets(s) and payment schedules negotiations with sites.
- Supports the coordination of feasibility activities as required in accordance with agreed timelines.
- Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
- Ensures the local country study files and filing processes are prepared set up and maintained as per PPD WPDs or applicable client SOPs.
- Maintains knowledge of and understand PPD SOPs Client SOPs/directives and current regulatory guidelines as applicable to services provided.
Keys to Success:
Education and Experience:
- Bachelors degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 2years).
In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Knowledge Skills Abilities:
- Effective oral and written communication skills.
- Excellent interpersonal skills.
- Strong attention to detail and quality of documentation.
- Good negotiation skills.
- Good computer skills and the ability to learn appropriate software.
- Good English language and grammar skills.
- Basic medical/therapeutic area and medical terminology knowledge.
- Ability to work in a team environment or independently under direction as required.
- Basic organizational and planning skills.
- Basic knowledge of all applicable regional/national country regulatory guidelines and EC regulations.
Why Join Us:
We hire the best develop ourselves and each other and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career and therefore you will benefit from an awardwinning learning and development programme ensuring you reach your potential.
What We Offer:
As well as being rewarded a competitive salary we have an extensive benefits package based around the health and wellbeing of our employees. We have a flexible working culture where PPD clinical research services truly value a worklife balance. Weve grown sustainably year on year but continue to offer a collaborative environment with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
